Xylitol for Otitis Media

Last updated: December 20, 2017
Sponsor: Duke University
Overall Status: Trial Not Available

Phase

2/3

Condition

Otitis Media

Soft Tissue Infections

Ear Infections

Treatment

N/A

Clinical Study ID

NCT02950311
Pro00072658
  • Ages 6-3
  • All Genders

Study Summary

This is a randomized, double-blind, placebo-controlled study of children, age 6 months to 3 years, with a diagnosis of Otis media with effusion (OME) based on examination by a provider at a Duke- affiliated otolaryngology clinic.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Between 6 months and 3 years of age.

  • Clinical diagnosis of OME. Treated at Duke for the above condition.

  • Ability of parent/guardian to be compliant with at-home nasal spray administration.

Exclusion

Exclusion Criteria:

  • History of immunodeficiency or an immunologic disorder that predisposes to frequentinfections.

  • History of prior pressure-equalization (PE) tube placement and the tubes are still inplace.

  • Active or recent (<1 month prior to screening) middle ear disease, including but notlimited to: cholesteatoma, tympanic membrane perforation, congenital external ormiddle ear abnormalities or malformations.

  • History of previous otologic surgery including tympanoplasty, and/or mastoidectomy.

  • Previous use of intranasal sprays other than normal saline, including intranasalsteroids, and/or xylitol within 1 month prior to screening.

  • Any other clinically significant illness or medical condition, per PI discretion, thatwould prohibit the subject from participating in the study.

  • Subject has previously been randomized to a trial of Xylitol.

  • Parent/guardian is unable to administer the study nasal spray.

  • Parent/guardian is unable to read, write, and understand English.

  • Parent/guardian is unable to provide legally effective consent.

Study Design

Study Start date:
November 20, 2017
Estimated Completion Date:
November 20, 2017

Study Description

The primary purpose of this study is to evaluate the efficacy of intranasal xylitol in young children with otitis media with effusion as measured by the resolution of middle ear effusion based on physical examination and tympanometry at 6-, 12-, and 18 and 24-weeks post-treatment. Eligible subjects will be randomly assigned to receive either intranasal xylitol spray or a nasal saline spray placebo and will be observed for 24-weeks following initiation of daily xylitol spray or placebo. The primary efficacy endpoint, the time to middle ear effusion resolution with and without the xylitol nasal spray, will be analyzed using either a two-sample t-test or non-parametric Wilcoxon test, depending on whether the time is normal or non-normal. Risks include epistaxis, diarrhea, and allergic reaction. Serious adverse events are not anticipated.